Cleared Traditional

K802930 - CYTOMEGALO VIRUS & CONTROLS

K802930 is an FDA 510(k) clearance for CYTOMEGALO VIRUS & CONTROLS, manufactured by Orion Diagnostica, Inc.. The device is a Class 2 Microbiology device with product code GQH cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K802930 · Orion Diagnostica, Inc. · Microbiology device
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Jan 1981
Decision
51d
Days
Class 2
Risk

K802930 is an FDA 510(k) clearance for the CYTOMEGALO VIRUS & CONTROLS. Classified as Antigen, Cf (including Cf Control), Cytomegalovirus (product code GQH), Class II - Special Controls.

Submitted by Orion Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1981 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K802930

510(k) Number K802930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1980
Decision Date January 09, 1981
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 102d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQH Device Classification - Class 2, Special Controls

Product Code GQH Antigen, Cf (including Cf Control), Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GQH Antigen, Cf (including Cf Control), Cytomegalovirus

All 18
Devices cleared under the same product code (GQH) and FDA review panel - the closest regulatory comparables to K802930.
CYTOMEGALOVIRUS
K843657 · Institute Virion , Ltd. · Sep 1985
CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II
K833089 · Clinical Sciences, Inc. · May 1984
CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM
K811671 · Zeus Scientific, Inc. · Sep 1981
CMV TEST KIT
K801963 · Immuno-Diagnostic Products, Inc. · Oct 1980
CMV BIO-BEAD TITRATION KIT
K801722 · Litton Bionetics · Sep 1980
FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS
K791948 · Intl. Diagnostic Technology · Nov 1979
K802930 · CYTOMEGALO VIRUS & CONTROLS
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